Risk Group Levels
Assessing risk is ultimately a subjective process. The investigator must make an initial risk assessment based on the risk group of the agent(s) being utilized in the activity. There are 4 risk groups as identified by The NIH Guidelines
, according to their relative pathogenicity for healthy adult humans. DePaul University currently can only support research with Risk Group 1 or 2 agents.
||Risk Group 1 agents not associated with disease in healthy human adults|
||Risk Group 2 agents are associated with human disease which is rarely serious and for which preventative or therapeutic interventions are often available.|
||Risk Group 3 agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available. (High individual risk, but low community risk)|
||Risk Group 4 agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. (High individual risk and high community risk)|
A complete list of which agents are classified in each Risk Group can be found in The NIH Guidelines
under Appendix B. Examples of RG1 include asporogenic Bacillus subtitles or Bacillius lichenformis. A strain of E. coli is considered RG1, if it does not possess a complete lipopolysaccharide (lacks the O antigen) and does not carry any active virulence factor or colonization factors and does not carry any genes encoding these factors. Additional information about Risk Groups can be found in the BMBL.
Biosafety Containment Levels
The Center for Disease Control (CDC) and NIH have established four levels that provide a combination of laboratory practices and techniques, containment or safety equipment, laboratory design, and laboratory facilities that are appropriate to the type of activity being performed and based upon the potential hazard of the agent being used. The levels are designated in ascending order, by degree of protection provided to personnel, the environment, and the community. Biosafety levels were created to represent the conditions under which the agent ordinarily can be safely handled. The four biosafety levels are described below. Generally, biological safety cabinets are not required for Risk Group 1 research. At this time, research and teaching activities at DePaul University can only involve agents requiring BSL1 & BSL2 containment procedures.
- Table 1: Summary of Recommended Biosafety Levels for Infectious Agents
- Table 2: Summary of Recommended Biosafety Levels for Activities in Which Experimentally or Naturally Infected Vertebrate Animals Are Used